MEasurement by a Numerical Approach of BREAst Volume MENABREA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- association between weight and volume adjusted to the density of the gland measured by electronic palpation
研究概览
简要总结
Breast asymmetry is a rare in plastic surgery. In majority of cases, it is idiopathic.
In cases that are poorly tolerated physically (vertebral imbalance, posture disorders) or psychologically, the decision to perform breast symmetrization surgery can be made. It is recommended to do this surgery after a slimming treatment if the woman is overweight or after pregnancy that causes a change in the structure and volume of the chest. In fact, the weight variations deteriorate the long-term result.
However, this surgical management remains difficult. In fact, the volume to be removed (unilateral breast reduction) to be symmetrized is a function of the volume of the contralateral breast and the preoperative drawings are made while standing. Currently, the evaluation of the volume to be removed remains subjective and is based on the experience of the surgeon. In addition, intraoperatively, this evaluation is also subjective because the patient is lying down which changes the position of the anatomical landmarks: the optimization of the symmetrization is only possible by the eye and the touch.
No measuring device is currently used to assess the difference in volume between the 2 breasts and guide the surgeon in the volume (or weight) to remove. It is therefore sometimes necessary to perform a second intervention in case of residual postoperative asymmetry.
Primary objective :
To study the association between the weight of tissues removed during the intervention and the variation of the breast volume (pre / postoperative) measured by the Créaform® GOPRO 3D digital camera adjusted on the density of the gland measured by electronic palpation (MyotonPRO).
Second objective : To study the association between the weight of tissues removed during the procedure and the variation of the breast volume (pre / postoperative) measured by the Créaform® GOPRO 3D digital camera adjusted on the density of the gland estimated by manual palpation (Likert scale from 1 to 5).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients referred for uni / bilateral breast reduction as part of an indication of surgical management.
- •Major patients.
- •Patients affiliated or beneficiaries of a social security scheme
- •Patients who have signed prior informed consent.
排除标准
- •Protected patients (pregnant, parturient and lactating women, persons deprived of their liberty by an administrative or judicial decision, persons undergoing psychiatric care under duress, minors, adults over the age of 18) legal protection measure or unable to express their consent).
- •Patients unfit to understand the objectives or instructions of the study.
- •Patients in an exclusion period relative to another interventional study.
研究组 & 干预措施
arm 1 : Creaform3D + MyotonPRO
A clinical questionnaire is completed by the investigator (chest circumference, thorax turn, breast "measurements").
The breast density is assessed by the surgeon and scored from 1 to 5 (Likert scale) and then by the MyotonPRO The volumetric measurement of the breast is performed using the 3D digital camera. The patient is bent forward with hands resting on a chair during 30 seconds to 1 minute. The 3D digital camera rotates around the breast to capture the volume of the breast.
Intraoperatively, the weight of tissues removed is weighed (in grams), recorded in the observation notebook.
In post-operative (4 months), the possible long-term complications related to the intervention (mainly the dissatisfaction of the patient as for the aesthetic result) are collected then a new acquisition of the mammary volume is carried out with the digital camera 3D.
Once this measurement is completed, participation in the study is complete
干预措施: arm 1 : Creaform3D + MyotonPRO (Other)
结局指标
主要结局
association between weight and volume adjusted to the density of the gland measured by electronic palpation
时间窗: one year
To study the association between the weight of tissues removed during the intervention and the variation of the breast volume (pre / postoperative) measured by the Créaform® GOPRO 3D digital camera adjusted on the density of the gland measured by electronic palpation (MyotonPRO). Primary judgment criterion: Coefficient associated with volume variation in the linear regression model (model 1) explaining weight by volume variation and density measured by electronic palpation.
次要结局
- association between weight and volume adjusted to the density of the gland estimated by manual palpation(one year)
- comparison of models 1 and 2(one year)